Intensive Chemotherapy And Immunotherapy In Patients With Newly Diagnosed Primary CNS Lymphoma
- Determine the complete response rate after remission induction therapy with the
combination of high-dose methotrexate (HDMTX), temozolomide, and rituximab at 4 months.
- Determine the safety and feasibility of consolidation therapy comprising cytarabine and
etoposide administered after induction therapy in these patients.
- Determine the percentage of patients who achieve durable (complete and partial)
remission when treated with this regimen.
- Determine relapse-free survival after complete response in patients treated with this
- Correlate molecular markers with outcome in patients treated with this regimen.
- Determine the effects of this regimen on neurological function in these patients.
OUTLINE: This is a multicenter study.
- Induction Chemotherapy: All induction therapy courses repeat every 28 days.
- Courses 1-3: Patients receive high-dose methotrexate IV over 4 hours on days 1 and
15, leucovorin calcium IV or orally every 6 hours beginning on days 2 and 16 and
continuing until blood levels of methotrexate are in a safe range, and oral
temozolomide on days 7-11. Patients also receive rituximab* IV on days 3, 10, 17,
and 24 of course 1 and days 3 and 10 of course 2 (total of 6 doses).
NOTE: *Patients diagnosed with T-cell primary CNS lymphoma do not receive rituximab.
- Course 4: Patients receive oral temozolomide on days 7-11, high-dose methotrexate IV
over 4 hours on day 15, and leucovorin calcium IV or orally every 6 hours beginning on
day 16 and continuing until blood levels of methotrexate are in a safe range. Patients
achieving a complete response or a complete response unconfirmed proceed to
- Consolidation therapy I (course 5): Beginning 4 weeks after the start of course 4,
patients receive high-dose methotrexate IV over 4 hours on day 1, leucovorin
calcium IV or orally every 6 hours beginning on day 2 and continuing until blood
levels of methotrexate are in a safe range, and oral temozolomide on days 7-11.
- Consolidation therapy II (course 6): Beginning 3-5 weeks after the start of course
5, patients receive cytarabine IV over 2 hours twice daily and etoposide IV over
12 hours twice daily on days 1-4 and filgrastim (G-CSF) or sargramostim (GM-CSF)
subcutaneously beginning on day 14 and continuing until blood counts recover.
Treatment continues in the absence of disease progression.
After completion of study treatment, patients are followed periodically for 3 years.
PROJECTED ACCRUAL: A total of 27-45 patients will be accrued for this study within 2-3
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response after remission induction
James L. Rubenstein, MD, PhD
University of California, San Francisco
United States: Federal Government
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|CCOP - Kansas City||Kansas City, Missouri 64131|
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|Fletcher Allen Health Care - University Health Center Campus||Burlington, Vermont 05401|
|Stony Brook University Cancer Center||Stony Brook, New York 11794-8174|
|SUNY Upstate Medical University Hospital||Syracuse, New York 13210|
|Rhode Island Hospital Comprehensive Cancer Center||Providence, Rhode Island 02903|
|Hematology Oncology Associates of the Quad Cities||Bettendorf, Iowa 52722|
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|
|Masonic Cancer Center at University of Minnesota||Minneapolis, Minnesota 55455|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Columbus, Ohio 43210-1240|
|Fort Wayne Medical Oncology and Hematology||Fort Wayne, Indiana 46815|
|Cancer Institute of New Jersey at Cooper - Voorhees||Voorhees, New Jersey 08043|
|Mountainview Medical||Berlin, Vermont 05602|
|Danville Regional Medical Center||Danville, Virginia 24541|
|Tunnell Cancer Center at Beebe Medical Center||Lewes, Delaware 19958|
|Menorah Medical Center||Overland Park, Kansas 66209|
|Saint Luke's Hospital - South||Overland Park, Kansas 66213|
|Shawnee Mission Medical Center||Shawnee Mission, Kansas 66204|
|Union Hospital Cancer Program at Union Hospital||Elkton MD, Maryland 21921|
|Truman Medical Center - Hospital Hill||Kansas City, Missouri 64108|
|St. Joseph Medical Center||Kansas City, Missouri 64114|
|North Kansas City Hospital||Kansas City, Missouri 64116|
|Saint Luke's Cancer Institute at Saint Luke's Hospital||Kansas City, Missouri 64111|
|Research Medical Center||Kansas City, Missouri 64132|
|Saint Luke's East - Lee's Summit||Lee's Summit, Missouri 64086|
|Liberty Hospital||Liberty, Missouri 64068|
|Heartland Regional Medical Center||Saint Joseph, Missouri 64506|
|Miriam Hospital||Providence, Rhode Island 02906|
|Parvin Radiation Oncology||Kansas City, Missouri 64116|